December 21, 2005

Clevland Clinic: Ties to Industry Cloud a Clinic's Mission

Dr. Eric J. Topol, a cardiologist, has been perhaps the most public face of the prestigious Cleveland Clinic Foundation, a prominent medical center regarded as one of the nation's best.

Not shy in the media spotlight, Dr. Topol has cultivated the persona of a Naderesque crusader against drugs he deems dangerous, as well as their makers. Some of his most impassioned criticism has been aimed at Merck and its drug Vioxx, the painkiller the company withdrew from the market over questions about its safety. But he has also been outspoken recently about other drugs.

Now, Dr. Topol's bluntness - refreshing to his admirers, startlingly unscientific to his targets and his critics - has drawn a bright spotlight to his own conduct and that of the Cleveland Clinic. In the last month, he has been demoted and the clinic's image has been tarnished in what has become an unusually public dispute pitting him against the clinic's chief executive, Dr. Delos Cosgrove.

Dr. Topol, who retains the position of chairman of cardiovascular medicine at the clinic, suggested in a Webcast on Thursday (http://www.theheart.org) that his unabashed willingness to take on Merck was a principal reason for his removal this month as head of the clinic's medical college. In what Merck lawyers have suggested is a vendetta, he described the company's behavior as "appalling" in recent testimony in a Vioxx lawsuit.

But his demotion has drawn attention to the mounting tensions between the clinic's research mission and its deep ties to the businesses that finance that research. Both Dr. Topol and Dr. Cosgrove refused to comment for this article, but associates say Dr. Topol may decide to leave the clinic.

The dispute at the Cleveland Clinic goes far beyond a simple power struggle between strong-willed men who competed for the clinic's top job. Dr. Topol severed his ties to industry after being embarrassed last December by an article in Fortune magazine. But the continued controversy has focused attention on the many longstanding corporate ties at the clinic. Those business links involve not only staff doctors and researchers, but also Dr. Cosgrove and the clinic's board.

The Cleveland Clinic is emblematic of the way the drug and medical device industries and the investment community work closely with medical researchers and doctors to develop and promote new medicines and technologies. Almost inevitably, such relationships raise concerns about possible conflicts of interest that could lead doctors to favor some treatments over others or to bias the results of medical research.

"It's not just the Cleveland Clinic," said Les Funtleyder, a health care strategist at the investment company Miller Tabak & Company in New York. He says other high-profile academic medical centers also have numerous financial ties that raise the potential for conflicts of interest.

Dr. Jerome P. Kassirer, a former editor in chief for The New England Journal of Medicine, describes the potential conflicts at the clinic "as extremely serious ones" but notes that the Cleveland Clinic is "not unique at all."

It was Dr. Topol's criticism of Merck that indirectly brought the clinic's conflicts to the fore. After the drug was withdrawn in September 2004 by Merck, Dr. Topol, who in journal articles had questioned the drug's cardiovascular safety, criticized the company's conduct.

Dr. Topol soon found himself under attack. He was the subject of the Fortune magazine article, which contended he had a conflict of interest. A hedge fund that listed Dr. Topol on its advisory panel had been a short seller of Merck's stock before the Vioxx withdrawal. Dr. Topol said he had nothing to do with the fund's action, which was a financial bet that the share price would fall.

Dr. Topol also found himself under fire at the clinic, where he would later claim that the chairman of the trustees, Malachi Mixon, had been contacted by Merck's chief executive at the time, Raymond V. Gilmartin. In any event, the clinic investigated Dr. Topol's business dealings, according to people briefed on the inquiry. Dr. Topol suggested in his Webcast that the clinic's pique might be related to the relationship between Mr. Gilmartin and Mr. Mixon, who attended Harvard Business School together.

Mr. Mixon, in an interview, would not discuss any conversations he had with Mr. Gilmartin on the subject. A Merck spokeswoman, however, denied that Mr. Gilmartin had ever contacted the Cleveland Clinic.

After the Fortune article, Dr. Topol publicly announced that he would cut all ties to industry, which included relationships with Eli Lilly, deCode Genetics and the Medicines Company - despite the fact that many doctors at the clinic and elsewhere had similar consulting deals.

"I think there's a real problem in academics today," he told The New York Times in January. "There's a very close-knit relationship with industry, and it's too close when any individual can derive a profit from that relationship."

The Cleveland Clinic itself was at the time finishing a set of ethical guidelines in which physicians and researchers were encouraged to continue working with industry, but were told that their ties would require reviews.

When his contract came up for renewal at the clinic at the end of last year, the clinic put Dr. Topol on a form of probation, giving him a six-month contract rather than the usual yearlong agreement, according to associates. It was a largely symbolic move, but associates said it angered Dr. Topol, who in 15 years at the clinic had been responsible for establishing the clinic's medical school and elevating the reputation of its cardiovascular medicine unit.

On the Webcast, Dr. Topol said the conflict-of-interest committee, on which he served, had looked into the financial arrangements of other doctors, including Dr. Cosgrove, as well as the fact that clinic patients were being used in tests of medical devices made by companies in which the clinic had financial interests.

Some of the clinic's perceived conflicts begin at the very top. Mr. BR Mixon, for example, is chief executive of Invacare, a major health care supply company. The company not only conducts about $200,000 a year in business with the clinic, but several people with clinic ties are on the Invacare board.

They include Dr. Bernadine Healy, the former head of the Red Cross who is married to Dr. Floyd D. Loop, the cardiac surgeon who led the clinic until he retired last year and was replaced by Dr. Cosgrove. Dr. Healy, who could not be reached for comment, owns options for 41,570 shares of stock in Invacare, according to a securities filing from earlier this year.

Mr. Mixon, who would not address other issues in this article, said his company's business dealings with the clinic constituted "peanuts" in the context of his company's overall annual revenue of about $1.5 billion.

A clinic spokeswoman, Eileen Sheil, said the clinic would not respond to questions about Mr. Mixon's company or Invacare's other board members.

Nor would the clinic address questions involving a number of Dr. Cosgrove's financial arrangements, although Ms. Sheil said he had severed those ties. In a statement, the clinic said it had begun an independent review of conflicts, to be conducted by an outside group.

Dr. Cosgrove, a well-regarded cardiac surgeon, is intimately familiar with the role physicians play in industry. His inventions include the Cosgrove-Edwards heart device, marketed by Edwards Lifesciences. The devices are used at the Cleveland Clinic, although the clinic would not discuss how or whether patients are informed of Dr. Cosgrove's connection when they are used.

Dr. Cosgrove also spearheaded the clinic's entrepreneurial efforts through a venture capital fund.

In an article last January, The New York Times described various companies in which the clinic had a financial interest, including AtriCure, the maker of a heart device. The Wall Street Journal featured AtriCure in a front-page article about the Cleveland Clinic this week.

All of this attention threatens to tarnish the clinic's image as an institution conducting world-class medical research. "All of these pieces of information coming out bit by bit are potentially damaging to the clinic's reputation," said Dr. Mildred K. Cho, a medical ethicist at Stanford University.

The clinic says its board of trustees has appointed an independent group to review the clinic's conflicts. But, in the meantime, Dr. Topol has been removed from the conflict-of-interest committee, a position he held by virtue of his leadership role at the medical college.

The publicity may prompt change, said Dr. Kassirer, the former medical journal editor. "The only question is whether it will really embarrass anyone. The clinic is so powerful, it has so much clout."